Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke

This study has suspended participant recruitment.

Sponsor:

Information provided by (Responsible Party):

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02059785

First received: February 7, 2014

Last updated: June 16, 2016

Last verified: October 2015

History of Changes

Purpose

This research is a Randomized, double-blind, placebo-controlled, multicenter clinical study. Chinese subjects with Ischemic Stroke.

Condition	Intervention	Phase
Ischemic Stroke	Drug: Pinocembrin for Injection	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke---Randomized, Double-blind, Placebo-controlled, Multicenter Study

Further study details as provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:

Primary Outcome Measures:

To determination the proportion of subjects that 0-1 score of mRS after treatment 90 days [ Time Frame: 90 days ]

Secondary Outcome Measures:

To compare treatment arms in terms of change from baseline to endpoint in NIHSS score. [ Time Frame: 90 days ]


Estimated Enrollment:	216
Study Start Date:	June 2013
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pinocembrin for Injection 40mg /60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day	Drug: Pinocembrin for Injection Other Name: DL0108
Placebo Comparator: placebo 60mg in 100ml of a solution of 0.9 percent saline,iv.drip bid,14day	Drug: Pinocembrin for Injection Other Name: DL0108

Detailed Description:

Subjects will randomly enter into one of two groups,the period of treatment is 14 days,follow-up to the 90th days.

Eligibility


Ages Eligible for Study:	35 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

35-75 hospitalized patients
Patients with acute stroke ≤24h
NIHSS score 6-20 at time of enrollment , the score ≥2 of item 5 and/or 6
For the first time or always without obvious sequelae of stroke disease(mRS≤1）
Informed consent

Exclusion Criteria:

The disease such as Acute intracerebral hemorrhage,tumor and encephalitis which cause similar symptoms
Patient with NIHSS level of consciousness score≥2 or dementia,or other patients who the investigator think that don't fit into the study
TIA
Symptoms of disease rapidly improving during the randomized
Severe hypertension(SBP > 200 mmHg or DBP >110 mmHg)
Inadequate liver function(AST or ALT greater than 2 times the upper limit of normal values);Renal impairment (Creatinine clearance ＜60ml/min）
Severe system or viscera organic disease
Have used other neuroprotectant or other experimental drugs
Patient who are unlikely to complete the study that due to a severe clinical condition
Pregnant or breast-feeding
Participation in a previous clinical study within 30 days
Meets all other exclusion criteria

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059785

Locations


China, Beijing
Beijing Tiantan Hospital affilliated to Capital Medical University
Beijing, Beijing, China, 100050

Sponsors and Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators


Study Director:	Wang Yong Jun, Ph.D	Beijing Tiantan Hospital affilliated to Capital Medical University

More Information


Responsible Party:	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02059785 History of Changes
Other Study ID Numbers:	CSPC-HA1301
Study First Received:	February 7, 2014
Last Updated:	June 16, 2016

Keywords provided by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.:


Pinocembrin for Injection Placebo mRS

Additional relevant MeSH terms:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia

ClinicalTrials.gov processed this record on July 17, 2017

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